[Cagdu] FW: [G-Dogs] Warning about injection used for heartworm prevention in dogs

[Tina Thomas]

Subject: Warning about injection used for heartworm prevention in dogs



Proheart 6, an injected drug to prevent heartworm, the
common parasite in dogs, has been temporarily withheld
in the US but is still currently available in Canada
and in Europe, according to the following article. 
This article tells of an FDA employee and her work to
have the above-mentioned veterinary drug banned., as
well as her reasons for doing so 
---

AP IMPACT: Sounding Alarm Over Pet Drug - New York
Times
The New York Times
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April 21, 2007

AP IMPACT: Sounding Alarm Over Pet Drug
By THE ASSOCIATED PRESS

Filed at 12:40 p.m. ET

BETHESDA, Md. (AP) -- The first hints of trouble came
with vague warnings from the outer reaches of the
bureaucracy.

She was ''pushing too hard.''

She was ''alarmist.''

But it was something else -- a clumsy bid to call her
off the scent of the dangerous veterinary drug she was
tracking -- that really galled her. Maybe that
was her last possible moment to keep soundless and
safe.

''When enough dogs die, this product will take care of
itself,'' a colleague said.

Her reply tumbled out like a boulder that, once
rolling, will no longer stop. Victoria Hampshire heard
herself say: ''I don't know what I'm doing here
then.''

What she was doing -- trying to do, at least -- was
her job: She kept count of side effects from animal
drugs for the
Food and Drug Administration.
She made tallies, analyzed numbers, and alerted
supervisors when something seemed amiss.

And something seemed amiss that spring of 2004.

A big drug maker had crafted what seemed a star
performer in Proheart 6, a three-year-old injected
drug to prevent heartworm, the common parasite in
dogs.
Hampshire's numbers showed, though, that dogs were
dying at alarming rates.

What happened next -- and the price she paid for
speaking up -- have spurred a
U.S. Senate
inquiry and shined a spotlight on the complex
topography of drug safety, where interests collide
like tectonic plates and squeeze decisions from all
sides.

On this landscape, the government's watchdogs come in
disparate breeds too. Some whimper at approaching
trouble; others bark gamely.

And some, like Hampshire, won't give an inch.

------

While dogs were dying, her dad's heart was failing.

Gifford Hampshire was an FDA press officer in the
1960s, when the agency firmly held the public trust.
There was no Vioxx scare, little fuss about taking
money from industry.

His daughter Victoria -- everyone called her Tory --
now worked as a veterinarian at the same agency. She
grew up on a Virginia horse farm, where her mother
raised basset hounds, and learned to treat animals
with compassion. She once crafted little sleeping bags
from cloth to help mice recover from surgery.

Her dad was so proud of her. She'd worked hard on her
government career. Then age 44, she was smart and
upstanding in everyday life too, someone who points
out undercharges and never speeds. But she wasn't
timid. When she'd stare over reading glasses, it
wasn't always fun to be her focal point.

''I could feel like I'd get an honest opinion from
her, without brownnosing,'' says Dr. Judith Davis, her
former supervisor at the
National Institutes of Health.
That meant Hampshire was not always ''a real subtle
person,'' says Dr. Linda Tollefson, who was deputy
head of the FDA's Center for Veterinary Medicine.

In summer 2004, Hampshire was analyzing Proheart 6
side effects for a fast-approaching showdown with drug
maker Wyeth. Evenings, she'd visit her dad at
the hospital. Then she'd work into the night.

She asked her dad if he wished she'd done anything
differently in her life. Be less intense and have more
fun, he suggested. That evening, she noticed an
old Jaguar for sale on the roadside. She wrote a
$1,000 check on the spot and drove it back to the
hospital. She made a martini for her dad and pointed
to the car parked outside.

It would be her last moment of comfort for a long,
long time.

------

Two days after his death, setting aside her grief,
Hampshire went toe-to-toe with Wyeth.

She and Tollefson clearly remember the confrontation
in a conference room at FDA headquarters. As adverse
events coordinator, Hampshire was anxious about
thousands of reported autoimmune, allergic, liver and
other reactions. Almost 500 dogs had died after taking
Proheart 6-- surpassing all competitors combined.

But Wyeth was known for strongly defending its drugs
from claims of harm. It had rallied for its estrogen
replacement and for its half of the fen-phen diet
combo. Its veterinary subsidiary, Fort Dodge Animal
Health, had sold 18 million doses of Proheart 6, worth
tens of millions of dollars. It surely wouldn't
give up without a fight.

Many vets also liked replacing pills with the
twice-a-year shot, which put heartworm prevention back
into their hands. One vet with ties to Wyeth lectured
colleagues about seizing on Proheart 6 as a ''hook''
to pull in healthy pets for profitable regular exams.

As the FDA meeting unfolded, the company said
Hampshire was inflating her side-effect numbers.
Things turned nastier when Hampshire said Fort Dodge
had
previously expressed its own concerns over tumors.
Fort Dodge said it hadn't.

''Either you're lying, or I'm imagining it,''
Hampshire erupted.

Dr. Stephen Sundlof, FDA's veterinary chief, grabbed
her hand under the table, silencing her, Hampshire
says. (He didn't answer messages seeking comment
for this story.)

''Tory did not have experience dealing with animal
pharmaceutical community people, who are not different
than the human pharmaceutical people. They make
a lot of money on this stuff. They will never ever
admit there's something wrong,'' says Tollefson, who
is now FDA's assistant commissioner for science.

On Sept. 4, 2004, in the face of Hampshire's damning
data, Wyeth ordered all Proheart 6 back from vets --
without conceding it was dangerous.

It was perhaps the largest recall ever of a pet drug.

------

Two months later, Wyeth's chief executive officer went
to FDA offices for a personal meeting with then-FDA
Commissioner Lester Crawford.

The CEO, Robert Essner, wanted to work out a big
problem: Victoria Hampshire.

His company had uncovered a Web site that gave
Hampshire a cut of its drug sales. Though Proheart 6
was sold there, Wyeth focused on competing drugs.

''We felt Dr. Hampshire had a conflict of interest in
regard to her evaluation of this product, and we
wanted the agency to be aware of it,'' says Wyeth
spokesman Doug Petkus.

FDA policy banned agency vets who moonlight from
taking payments by pharmacies independent of their own
practices. But so many staffers unknowingly violated
the rule that it was rewritten the next year.

Hampshire acknowledges using the Web site, mainly to
prescribe drugs for pets of old clients and friends,
without needing to warehouse medicines at her
Bethesda home. She says she meant to drop the site and
hadn't bothered to disclose it as an outside activity
that year -- a bad decision, she now acknowledges.
But an invoice shows her earnings were a mere $160
over 2 1/2 years.

Wyeth also accused her of inciting complaints from dog
owners like Jean Brudd, of Thornton, Colo., who had
contacted the FDA about the deaths of her two
dogs.

In one e-mail to Brudd, Hampshire had written that
''autoimmune disease is being reported in growing
numbers'' and laid out how Brudd's friends could
submit
side-effect reports.

Hampshire says it was her duty to check complaints and
help people navigate the FDA.

Wyeth wanted Hampshire reassigned and threatened to
sue her, says agency manager Tollefson, though Wyeth
denies it.

In the end, Crawford ''thought it best ... to protect
Tory to get her out of it completely,'' explains
Tollefson, who was briefed after the top-level
meeting.
She says she and Sundlof, the center head, agreed to
transfer Hampshire.

Tollefson says they also wanted to keep her from being
a ''distraction'' when the recall was reviewed,
because they too were troubled by the drug's safety
record.

Crawford didn't respond to interview requests for this
story. In 2005, he abruptly quit the FDA and later
admitted hiding stocks he owned in medical and
food companies it regulated. He was fined about
$90,000.

But former FDA lawyer Daniel Troy, also at the
Essner-Crawford meeting, defends how it was handled.
''At the same time the FDA is actually getting smashed
and bashed by the news media on conflicts of interest,
here there was an allegation of conflict of interest,
and the FDA took it seriously,'' he says.

------

One morning two months later, Hampshire was working on
Proheart 6 data when she was called in to the
veterinary director's office without explanation.

There, in a bright office decorated with a folksy
painting of dairy cows, Tollefson waited with an FDA
manager of market reviews. Hampshire figured they
needed help as the FDA prepared to reconsider the
Proheart 6 recall.

But Tollefson inhaled sharply, as if steeling herself.
Then she wiped a tear from her eye. Hampshire had
known Tollefson since working at the health
institutes;
they were friendly, but she'd never seen anything like
this.

''Wyeth has pulled all the plugs at the level of
commissioner,'' Tollefson told a stunned Hampshire.
They were transferring her to the vaccines building
to care for the rats and monkeys.

She pleaded for her job. They refused to give details
but reassured her that this would all blow over. She
was likened to a cop who'd shot somebody in the
line of duty.

''I haven't shot anybody,'' she protested. ''I've done
my job.''

She left the office in tears.

Her shame deepened when a committee of FDA advisers
took up the Proheart 6 recall three weeks later in
January 2005. She wasn't allowed to talk to them,
and they voted just barely, 8-7, to keep the drug off
the market for the time being.

The next month, an agency inspector from Internal
Affairs asked to see Hampshire. He told her she was
under investigation over Wyeth objections to her
outside
activities. He referred obscurely to a ''sinister
plot.''

A prosecutor had already ruled out most criminal
charges. But the inspector made her sign a statement
saying she could be fired and, if she lied, charged
with perjury. He reminded her about the jailing of
domestic guru
Martha Stewart
over a financial conflict.

------

Hampshire dragged herself through the next several
months, feeling she'd been cast, weak and worthless,
into a hole. A colleague worried she was headed
for a breakdown.

She was sent to an interim FDA office job within the
capability of ''anybody with half a brain,'' she says.
She didn't know where the investigation would
lead. She didn't know who might be bent on ruining her
career, but she looked for a better job somewhere. She
saw -- or imagined -- warning signs and potential
enemies everywhere. She hoped for protection from
members of Congress she contacted.

She fretted at home. ''To take this much stress home
and not to sleep for weeks is not worth it,'' she
says. Even her two children noticed changes in her.

Then, out of the blue, there was a flicker of light.
In April 2005, she landed a better job in the FDA
itself, at a separate office that evaluates devices
for the human heart. ''It sounded to me like she
really hadn't done anything wrong,'' explains her new
supervisor, Dave Buckles.

That July, more relief came: Hampshire was told she
was cleared by agency investigators. ''A valued
employee'' is how FDA spokeswoman Julie Zawisza now
describes her, but she won't discuss the transfer and
investigation.

Tollefson now believes the affair was mishandled.
''Everybody saw that we reassigned Tory, no
explanation was ever given -- not a good one -- so the
message
to me was very clear: If you do your job right and
you're questioned, you lose your job.''

Although Wyeth has been sued on behalf of dozens of
people whose pets took Proheart 6, the company hopes
to be vindicated too. It has kept selling the drug
in Canada, Europe and elsewhere, and it has approached
the FDA with more data for a possible U.S. comeback.

In June 2005, a Wyeth manager made a sales call at an
Alabama veterinary practice, where he openly blamed
Hampshire for the Proheart 6 recall, according
to a confidential letter written by a vet there to the
FDA. The Wyeth employee boasted that the company had
her investigated by private detectives, and
she had been ''taken care of,'' according to the
letter obtained by The Associated Press. He then
predicted the drug's swift return to market.

That Wyeth manager, Glen Kimmorley, did not answer AP
messages left at a home phone in his name. The Wyeth
spokesman said Kimmorley ''was expressing his
own opinion and was not authorized to speak on behalf
of the company.''

However, Sen.
Chuck Grassley,
R-Iowa, who has been investigating Hampshire's case,
says Wyeth ''tried to destroy a reputation.''

He added: ''Her own agency sold her down the river.''

------

Hampshire still feels edgy, less trusting, shamefully
naive about corporate influence on government. Her
husband, Bob Balaban -- himself a senior scientist
at the National Institutes of Health -- says she's
''not the same person.'' They hope for more answers
from Senate investigators.

Others have reached their own conclusions. Last year,
Hampshire was sitting in a big conference room in
Denver at a veterinary meeting of the U.S. Public
Health Service. The agency was announcing its
veterinarian of the year. She grabbed her camera to
photograph the winner.

And then, as if scripted by Hollywood, her own name
was announced.

She heard a health officer say she had ''raised the
bar in every category of professional and personal
integrity, passion, and commitment.''

People rushed over to hug her. For the first time in
years, she let down her guard.

Copyright 2007 The Associated Press

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